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| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Quality Management System (QMS) Requirements | 25–30% | - Support, operation, performance evaluation, improvement - Context of the organization, leadership, planning - Scope, normative references, terms and definitions |
| Topic 2: Conducting an ISO 9001 Audit | 15–20% | - Evaluating conformity, identifying nonconformities - Team meetings, audit observations - Opening meeting, on-site activities, evidence collection |
| Topic 3: Preparation of an ISO 9001 Audit | 10–15% | - Document review and communication - Selecting audit team, preparing plan and checklist - Initiating audit, defining objectives and scope |
| Topic 4: Fundamental Principles and Concepts of Quality Management System | 10–15% | - Relationship between ISO 9001 and other standards - Quality management principles - Concepts of QMS, risk, process approach |
| Topic 5: Closing an ISO 9001 Audit | 5–10% | - Preparing conclusions, closing meeting - Audit report, follow-up actions |
| Topic 6: Managing an ISO 9001 Audit Program | 5–10% | - Establishing, implementing and monitoring audit program - Competence and evaluation of auditors |
| Topic 7: Fundamental Audit Concepts and Principles | 10–15% | - ISO 19011 and ISO/IEC 17021-1 requirements - Independence, evidence-based approach - Audit principles, types, roles and responsibilities |
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질문 # 206
Read the following role descriptions. Select two roles that are not directly involved in the audit process.
정답：C,D
질문 # 207
XYZ Corporation is an organisation that employs 100 people. As audit team leader, you are conducting a certification audit at Stage 1. When reviewing the quality management system (QMS) documentation, you find that quality objectives have been set for every employee in the organisation except top management.
The Quality Manager complains that this has created a lot of resistance to the QMS, and the Chief Executive is asking questions about how much it will cost. He asks for your opinion on whether this is the correct method of setting objectives.
Three months after Stage 1, you return to XYZ Corporation to conduct a Stage 2 certification audit as Audit Team Leader with one other auditor. You find that the Quality Manager has cancelled the previous quality objectives for all employees and replaced them with a single objective for himself. This states that "The Quality Manager will drive multiple improvements in the QMS in the next year". The Quality Manager indicates that this gives him the authority to issue instructions to department managers when quality improvement is needed. He says that this approach has the full backing of senior management. He shows you the latest Quality Improvement Request that was included in the last management review.
After further auditing, the issues below were found. Select three statements that apply to the term 'audit trail'
정답：C,D,E
설명：
Based on the scenario and the concept of an 'audit trail' within the context of ISO 9001, the three statements that apply would likely be:
A). Decisions on improvement action timescales not involving departmental managers. This indicates a lack of involvement and communication with those responsible for implementing the improvements, which is a key part of an effective audit trail1.
B). Evaluation of the results of the improvement action not always documented by the Quality Manager.
Proper documentation is essential for an audit trail, as it provides evidence that actions have been evaluated and are effective1.
C). Limited knowledge of the content of Quality Improvement Requests by departmental staff. An audit trail should ensure that all relevant parties are aware of and understand the actions being taken, which is not the case here1.
These points suggest issues with the communication, documentation, and involvement of relevant personnel in the quality management system processes, which are crucial for maintaining an effective audit trail and, by extension, a robust quality management system.
질문 # 208
Select the words that best complete the sentence:
정답：
설명：
Explanation:
According to the ISO 19011:2018 document, the audit plan should provide the basis for agreement regarding the conduct and scheduling of the audit activities. The amount of detail provided in the audit plan should reflect the scope and complexity of the audit, as well as the risk of not achieving the audit objectives1. The scope of the audit refers to the extent and boundaries of the audit, such as the audit criteria, the audit objectives, the organizational and functional units, and the processes to be audited1. The complexity of the audit refers to the degree of difficulty or intricacy of the audit, such as the number and diversity of the auditees, the audit criteria, the audit methods, and the audit team composition2. The risk of not achieving the audit objectives refers to the possibility that the audit may fail to provide reliable and sufficient audit evidence to support the audit conclusions and report1.
Therefore, the complete sentence is:
In the context of a third-party audit, the amount of detail provided in the audit plan should reflect the scope and complexity of the audit, as well as the risk of not achieving the audit objectives.
References: 1: ISO 19011:2018 - Guidelines for auditing management systems 2: Audit Complexity - an overview | ScienceDirect Topics
질문 # 209
Who assigns a guide to assist the audit team?
정답：A
설명：
Comprehensive and Detailed In-Depth Explanation:According to ISO 19011:2018, Clause 6.4.3 (Roles and Responsibilities of Guides and Observers):
* The auditee assigns a guide to assist the audit team.
* The guide provides logistical support, helps with navigation, and arranges access to necessary personnel and records.
* The audit team leader does not assign the guide, but they may request one.
질문 # 210
You are the supervisor in Production of a medium size manufacturing organisation. You are qualified as an internal auditor. The Quality Manager asks you to lead the next internal audit of Production and Logistics Dispatch. The audit team includes two other internal auditors.
정답：
설명：
Explanation:
Here is the correct matching of actions to the statements in the context of leading the internal audit:
* If practicablecarry out a formal opening meeting
* You should notaudit production (as you are a supervisor in that area, and this would compromise audit objectivity)
* You need notchange the audit team (unless there is a specific reason, such as conflict of interest)
* You mustraise audit findings if necessary (this is a key responsibility of an auditor when nonconformities are found)
* You must notsend the audit report to the Quality Manager (the audit report must be reviewed first; it is typically part of the internal audit process to go through necessary channels before final submission)
* You shouldsend the audit report to the Quality Manager (after appropriate reviews and approvals) This reflects key principles of conducting an internal audit according to ISO 9001:2015, ensuring objectivity, proper documentation, and clear reporting procedures.
질문 # 211
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참고: Itexamdump에서 Google Drive로 공유하는 무료 2026 PECB ISO-9001-Lead-Auditor 시험 문제집이 있습니다: https://drive.google.com/open?id=1GjnhgmLQ2mI_Sh8thwU3KNVOQVYH205F